Clinical Trial for Evaluating the Efficacy and Safety of Electrocoagulation vs Topic Sinecatechins vs Topic Cidofovir Within the Treatment to High-grade Anal Intraepithelial Neoplasia in HIV Homosexual Males

• Status: Not yet recruiting
• Trial end date: 2022-04-01
• Target enrollment: 0
• Participant gender: Male

Summary

This study wants to demonstrate the non-inferiority in terms of efficacy and safety of treatment with cidofovir (1%) in topical ointment or topical sinecatechins (10%) ointment versus electrocoagulation (control group) for the treatment of high-grade anal intraepithelial neoplasia (HGAIN).

The target patients are Human Immunodeficiency Virus (HIV)-infected homosexual males.

All these patients will be randomized by a proportion of 1:1:1 setting up 3 different parallel arms of the study: control group, cidofovir (1%) group and topical sinecatechins (10%) group.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hospital Universitari Vall d'Hebron Research Institute
• Treatments: Cidofovir

Criteria

Inclusion Criteria:

• Men who have sex with men, older or same than 18 years old.

• HIV-1 positive men.

• High grade anal intraepithelial neoplasia recognised by biopsy during 12 months previous to study.

• Informed consent is signed voluntarily.

Exclusion Criteria:

• Patient with any disease or condition which rules him out to participate in the research, by investigator opinion.

• Treated patients for HGAIN in the previous 6 months.

• Patients with relapsed HGAIN two or more times in the last three months.

• People with learning difficulties